Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers kits distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential endotoxin contamination, which poses a risk of harm to patients. No specific illnesses or injuries are reported in the source text, placing this in the High severity category.
Plain-English summary
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kits. The recall is being conducted because of potential endotoxin contamination in the affected products.
The recall includes 116,652 kits distributed worldwide, including in the United States and numerous international markets. The affected product part numbers are 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, and 0684-00-0480-10.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative according to the instructions provided in the recall communication.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 116,652
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Datascope Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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